MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	711.13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during vitrectomy surgery a vitreous forceps was broken, and a piece fell into the eye.The surgery was completed after replacing the product with another one.Patient impact was not reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in its inner blister, covered with the tyvek lid foil showing the lot information.The product shows macroscopic signs of damage, namely that one of the forceps arms is broke off.There are sign surgery residues.The instrument was visually inspected with the aid of a photomicroscope with various magnifications.The visual inspection shows the fracture in detail.The three trocar cannulas supplied were also inspected, and the broken forceps arm was not found in any of the cannulas.The images of the fracture show a typical structure achieved by the hardening process.Despite different types of structure, the structure can therefore be ruled out as the sole cause of the fracture.The root cause itself can no longer be evaluated, as the instrument underwent 100% inspection during production and only broke at the user's premises.Based on the investigation results, it is no longer possible to determine what led to this breakage.The provided video shows how the membrane is peeled off using the forceps.During the process, one of the forceps' arms breaks.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.No root cause for the customers reported event could be determined, since the situation that led to the instrument failure cannot be reconstructed.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.The complaint data will continue to be monitored for evidence of adverse trending and further action will be taken, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22148398
• Report Number: 3003398873-2025-00309
• Device Sequence Number: 7849729
• Product Code: HNR
• UDI-Device Identifier: 07612717071292
• UDI-Public: (01)07612717071292(17)270630(11)240701(10)16XE2U
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 711.13
• Device Lot Number: 16XE2U
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown